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A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules

A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04905056
Enrollment
120
Registered
2021-05-27
Start date
2021-01-01
Completion date
2028-12-31
Last updated
2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progression

Brief summary

A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Interventions

Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Aged between 18 and 85 years; 2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT); 3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm; 4. For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm 5. The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest 6. The patient is able to understand and comply with the study and has provided written informed consent

Exclusion criteria

1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial 2. had severe disease conditions 3. allergy to narcotic drugs 4. had other autoimmune disease 5. dementia or cognitive impairment can't cooperate with researchers 6. any local treatment other than ablation was received within 4 weeks before the study

Design outcomes

Primary

MeasureTime frameDescription
progression free survival1 yearsOne year progression free survival after radiofrequency ablation of ground glass nodules

Secondary

MeasureTime frameDescription
overall survival1 years, 3 years, 5yearsoverall survival after radiofrequency ablation of ground glass nodules

Countries

China

Contacts

Primary ContactQun Wang, Phd
13301050210@fudan.edu.cn86-21-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026